Kelvi Clinician Terms and Conditions

These Terms and Conditions ("Terms") are an agreement between you and Hypothermia Devices, Inc., doing business as Kelvi ("Kelvi," "we," "us"). They govern your use of the Kelvi Clinician app for iOS and Android (the "app") and the services provided through it. By creating an account or using the app, you agree to these Terms, including the business associate terms in Section 10, and to our Clinician Privacy Policy. If you do not agree, do not use the app.

If you use the app on behalf of a healthcare practice or other organization, you agree to these Terms on its behalf and confirm that you are authorized to do so. In that case, "you" includes that organization.

1. About the app and professional judgment

The app works with Kelvi heating and cooling therapy devices ("Kelvi devices"). It lets healthcare professionals create treatments, assign them to patients, run and monitor treatments on Kelvi devices, review patient treatment history and install Kelvi device software updates.

The app is a tool to support your care. It is not a substitute for your professional judgment. You are solely responsible for using due care and independent professional judgment in prescribing, programming and delivering treatments, and in your use of the app and any information in it. You are also responsible for following the laws and professional standards that apply to your practice, including those for medical records. Use Kelvi devices in accordance with their instructions for use.

Information in the app, including any educational content, is provided for informational purposes. The app is not intended for medical emergencies.

2. Eligibility and your account

The app is intended for use by healthcare professionals in the United States and its territories.

You agree to provide accurate information when you create your account and to keep it up to date. Each person who uses the app must have their own account. Do not share your login. You are responsible for keeping your phone and password secure and for all activity under your account, and we may treat activity under your account as yours.

3. Your patients

You may invite patients to the app and link your account with theirs. Linking is optional, and patients' accounts are their own: they can use the app without you, and the link can be removed at any time.

You are responsible for having any authority and consent you need to enter a patient's information into the app, to invite them, and to assign treatments to them. You may not invite or register a patient under 13 years old.

The app is not intended to be your system of record. Keep any patient records you need in your own systems. Deleted data cannot be recovered, and a patient who deletes their account removes their data from your view.

4. Privacy, de-identified data and communications

Our Clinician Privacy Policy explains how we collect, use and share your information, and is part of these Terms. Patient information you enter or access through the app is also covered by the business associate terms in Section 10.

We may create de-identified data from treatment information. Where Section 10 applies, we do so only as it permits. De-identified data has had names, email addresses and anything else that identifies you or your patients removed. We use it to develop and improve heating and cooling therapy protocols and our products.

You agree that we may send you notices and messages about your account and the app by email, including account verification, password resets and notices about these Terms.

5. License and restrictions

Kelvi owns the app, its content and all updates, including all intellectual property rights in them. Subject to these Terms, we grant you a limited, non-exclusive, non-transferable, revocable license to install and use the app on devices you own or control, in the ordinary course of your professional practice. On Apple devices, this license is also subject to the Usage Rules in the Apple Media Services Terms and Conditions.

You may not:

• Copy, modify or create derivative works of the app or its content
• Reverse engineer, disassemble or attempt to derive the app's source code, except where the law or an applicable open-source license allows it
• Sell, rent, sublicense, distribute or share the app, or make it available over a network where multiple devices can use it at the same time
• Use the app on behalf of any healthcare organization other than your own practice
• Use the app to harass, abuse, threaten or defame anyone
• Use the app in violation of any law, or interfere with or try to gain unauthorized access to the app, our servers or other users' accounts

If you sell or give away a device with the app on it, delete the app first.

We may release updates to the app. Some features may require the latest version.

6. Devices, software updates, availability and third-party services

You are responsible for a compatible phone or tablet, its operating system, internet access and Bluetooth, and for any data charges. The app is available through the Apple App Store and Google Play, and your use of those stores is governed by their own terms.

The app can install software updates on Kelvi devices. Install only updates offered through the app, and only on Kelvi devices you are authorized to use.

We work to keep the app available but do not guarantee it will always be available or free of errors. It may be unavailable because of maintenance, loss of internet or Bluetooth connection, or problems with services provided by third parties. If the app loses its connection to a Kelvi device, a treatment can be controlled or stopped directly on the device. We may change, suspend or discontinue any part of the app at any time.

Some functions of the app rely on services provided by third parties, such as hosting providers. Kelvi is not responsible for third-party services or content that are not under our control.

7. Account deletion and termination

You may stop using the app and delete your account at any time, in the app by opening Settings, then selecting Delete Account, or by requesting deletion at kelvi.com/delete-account. Deletion is permanent and cannot be undone. It removes the treatment plans you created, the assignments you made and the sessions you ran, including from the accounts of patients linked to you. The Clinician Privacy Policy explains what is deleted.

We may suspend or end your access to the app if you breach these Terms, if the law requires it, or if we discontinue the app. We will notify you by email when we reasonably can.

When your access ends, your license to use the app ends. Sections 5, 8, 9, 10, 11 and 13 continue to apply.

8. Disclaimer

THE APP AND ALL CONTENT AND SERVICES PROVIDED THROUGH IT ARE PROVIDED "AS IS" AND "AS AVAILABLE." TO THE MAXIMUM EXTENT PERMITTED BY LAW, KELVI MAKES NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT, AND DOES NOT WARRANT THAT THE APP WILL MEET YOUR REQUIREMENTS OR OPERATE WITHOUT INTERRUPTION OR ERROR. THIS SECTION DOES NOT AFFECT ANY SEPARATE WARRANTY THAT APPLIES TO A KELVI DEVICE.

9. Limitation of liability

To the maximum extent permitted by law:

• Kelvi is not responsible for any harm, loss or damage caused or contributed to by you, anyone in your practice, a patient or a third party, including errors or omissions in information entered into the app.
• Kelvi will not be liable for any indirect, incidental, special, consequential or punitive damages, or for lost data, arising from or relating to your use of the app.
• Kelvi's total liability for any claim arising from or relating to the app is limited to $100.

Some jurisdictions do not allow certain limitations of liability, so some of these limitations may not apply to you. Nothing in these Terms limits Kelvi's liability for death or personal injury caused by its negligence, or for fraud, gross negligence or willful misconduct.

10. Business associate terms

This Section applies if you are a "covered entity" under HIPAA. It is the business associate agreement between you and Kelvi for the protected health information ("PHI") that Kelvi creates, receives, maintains or transmits on your behalf through the app. "HIPAA" means the Health Insurance Portability and Accountability Act of 1996, the HITECH Act and their regulations at 45 C.F.R. Parts 160 and 164. Other terms used in this Section that are defined in HIPAA have the meanings given there.

10.1 Permitted uses and disclosures. Kelvi may use and disclose PHI only:

• To provide the app and related services to you, including installing, maintaining, updating and supporting the app and Kelvi devices
• For Kelvi's proper management and administration and to carry out its legal responsibilities. Kelvi may disclose PHI for these purposes only if the disclosure is required by law, or if Kelvi first obtains reasonable assurances from the recipient that it will keep the PHI confidential, use or further disclose it only as required by law or for the purpose for which it was disclosed, and notify Kelvi of any breach of its confidentiality.
• To de-identify PHI in accordance with 45 C.F.R. § 164.514(a) through (c). De-identified information is not PHI, and Kelvi may use and disclose it for any lawful purpose, including developing and improving heating and cooling therapy protocols and its products.
• As required by law
• As otherwise permitted in writing by you, or by a valid authorization from the patient, to the extent HIPAA allows

Except as permitted for management and administration above, Kelvi will not use or disclose PHI in any way that would violate HIPAA if done by you.

10.2 Prohibited uses. Kelvi will not sell PHI or receive payment in exchange for PHI except as HIPAA permits, and will not use PHI to market to your patients.

10.3 Safeguards. Kelvi will use appropriate administrative, physical and technical safeguards, and will comply with the HIPAA Security Rule (Subpart C of 45 C.F.R. Part 164) for electronic PHI, to prevent use or disclosure of PHI other than as this Section provides.

10.4 Subcontractors. Kelvi will ensure that any subcontractor that creates, receives, maintains or transmits PHI on Kelvi's behalf agrees in writing to the same restrictions, conditions and requirements that apply to Kelvi under this Section.

10.5 Reporting. Kelvi will report to you any use or disclosure of PHI not provided for by this Section, and any security incident, of which it becomes aware, including any breach of unsecured PHI as required by 45 C.F.R. § 164.410. Kelvi will notify you of a breach of unsecured PHI without unreasonable delay and no later than 30 business days after discovering it. Kelvi will provide, to the extent available, the identity of each affected individual and the other information you need to meet your own notification obligations. This Section is notice of the ongoing occurrence of unsuccessful security incidents, such as pings, port scans and unsuccessful log-in attempts, that do not result in unauthorized access to or use or disclosure of PHI, and no further notice of them is required. Kelvi acts as an independent contractor, not as your agent.

10.6 Patient requests. Patients' requests to access or amend their PHI, to restrict its use or disclosure, or for an accounting of disclosures should be directed to you. If a patient contacts Kelvi with such a request, Kelvi will refer them to you. At your request, and within a reasonable time, Kelvi will make PHI available to you as needed for you to meet your obligations under 45 C.F.R. § 164.524, make amendments to PHI as you direct under § 164.526, and provide the information you need to give an accounting of disclosures under § 164.528.

10.7 Your obligations carried out by Kelvi. To the extent Kelvi carries out any of your obligations under the HIPAA Privacy Rule (Subpart E of 45 C.F.R. Part 164), Kelvi will comply with the requirements of that Subpart that apply to you in carrying them out.

10.8 Books and records. Kelvi will make its internal practices, books and records relating to the use and disclosure of PHI available to the Secretary of Health and Human Services for purposes of determining your compliance with HIPAA. Kelvi will keep records of its security policies, subcontractor agreements, accountings of disclosures, security incident reports and other documentation HIPAA requires for at least six years.

10.9 Your responsibilities. You will not ask Kelvi to use or disclose PHI in any way that would not be permitted under HIPAA if done by you. You will tell Kelvi about any limitation in your notice of privacy practices, or any restriction you have agreed to with a patient, that affects Kelvi's use or disclosure of PHI.

10.10 Term and termination. This Section applies for as long as Kelvi holds PHI on your behalf. If Kelvi materially breaches this Section, you may end these Terms by deleting your account. When your account is deleted or these Terms otherwise end, Kelvi will destroy the PHI it holds on your behalf, as described in Section 7 and the Clinician Privacy Policy. PHI that remains in a patient's own account is held for that patient, not on your behalf. If destroying any PHI is not feasible, Kelvi will extend the protections of this Section to it and limit further use and disclosure to the purposes that make destruction infeasible.

10.11 Interpretation. If this Section conflicts with any other part of these Terms, this Section controls for PHI. This Section will be interpreted to comply with HIPAA, and Kelvi may update it as needed to comply with changes in HIPAA, as described in Section 12. This Section gives no rights to any third party.

11. Dispute resolution and governing law

These Terms are governed by the laws of the State of California, without regard to its conflict of laws rules, and by applicable federal law.

Any dispute, claim or disagreement arising from or relating to these Terms or the app will be resolved by binding arbitration administered by the American Arbitration Association under its applicable rules. The arbitrator's decision is final, and judgment on the award may be entered in any court with jurisdiction.

There are two exceptions. Either party may bring an individual claim in small claims court if it qualifies. Either party may also go to court to seek injunctive relief for the infringement or misuse of its intellectual property, including an actual or threatened violation of Section 5.

Any court proceeding permitted under these Terms, including one to enforce an arbitration award, will be brought in the state or federal courts located in Los Angeles County, California, and you and Kelvi consent to their jurisdiction.

The prevailing party in any arbitration or court proceeding is entitled to its reasonable attorneys' fees and costs.

12. Changes to these Terms

We may update these Terms from time to time. We will post the updated Terms on this page and change the effective date above. For material changes, we will notify you by email or through the app at least 30 days before they take effect. If you continue to use the app after changes take effect, you accept the updated Terms. If you do not agree, stop using the app and delete your account.

13. General

• Assignment. You may not assign or transfer these Terms. Kelvi may assign them to any successor that agrees to be bound by them.
• Entire agreement. These Terms and the Clinician Privacy Policy are the entire agreement between you and Kelvi about the app. They replace any earlier agreements about the app.
• Severability. If any part of these Terms is found unenforceable, the rest remains in effect.
• No waiver. If we do not enforce any part of these Terms, that is not a waiver of our right to enforce it later.
• Electronic agreement. These Terms are an electronic contract, and accepting them in the app is your electronic signature. You may request a paper copy at info@kelvi.com.

14. Contact us

If you have any questions about these Terms, you can contact us:

• By email: info@kelvi.com
• By visiting this page on our website: kelvi.com/contact